CHICAGO - Americans with diabetes nearly doubled their spending on drugs for the disease in just six years, with the bill last year climbing to an eye-popping $12.5 billion.Newer, more costly drugs are driving the increase, said researchers, despite a lack of strong evidence for the new drugs' greater benefits and safety. And there are more people being treated for diabetes.

The new study follows updated treatment advice for Type 2 diabetes, issued last week. In those recommendations, an expert panel told doctors to use older, cheaper drugs first.

And a second study, also out Monday, adds to evidence that metformin — an inexpensive generic used reliably for decades — may prevent deaths from heart disease while the newer, more expensive Avandia didn't show that benefit.

"We need to pay attention to this," said Dr. David Nathan, diabetes chief at Boston's Massachusetts General Hospital, who wrote an editorial but wasn't involved in the new studies. "If you can achieve the same glucose control at lower cost and lower side effects, that's what you want to do."

The studies, appearing in Monday's Archives of Internal Medicine, were both funded by federal grants.

‘A remarkable change’

In one, researchers from University of Chicago and Stanford University looked at which pills and insulin doctors prescribed and total medication costs. Diabetes drug spending rose from $6.7 billion in 2001 to $12.5 billion in 2007, a period when costs dropped for metformin.

More patients got multiple prescriptions as new classes of drugs came on the market. And more patients with diabetes were seeing doctors, increasing from 14 million patients in 2000 to 19 million in 2007.

"There's been a remarkable change in diabetes treatments and remarkable increases in the cost of treatments over the past several years," said study co-author Dr. Caleb Alexander, assistant professor of medicine at the University of Chicago. "We were surprised by the magnitude of the changes and the rapid increase in the cost of diabetes care."

Nearly 24 million Americans, 8 percent of the population, have Type 2 diabetes, which can lead to kidney failure, blindness and heart disease.

Current guidelines say doctors should prescribe metformin (about $30 a month) to lower blood sugar in newly diagnosed patients and urge them to eat healthy food and get more exercise. Other drugs can be added later, on top of metformin, to help patients who don't meet blood sugar goals. The updated guidelines don't include Avandia, which costs about $225 a month.

Dr. Susan Spratt, an endocrinologist at Duke University Medical Center, said she prescribes whatever it takes to lower her patients' future risk of blindness and amputations. That can mean coupling more costly drugs with metformin to hit blood sugar goals.

"I think cost-analysis is important from a public health standpoint," Spratt said. "But when you're sitting across from a patient, you want to use whatever is going to help them get control of their diabetes."

‘Critical need’

In the other study, Johns Hopkins University researchers analyzed findings from 40 published trials of diabetes pills that measured heart risks. Compared to other diabetes drugs or placebo, metformin was linked to a lower risk of death from heart problems.

The findings hint that Avandia has a possible increased risk for heart disease death, but that increase wasn't statistically significant, meaning it could have been the result of chance.

Few of the studies lasted longer than six months. The researchers cited a "critical need" for long-term studies of diabetes pills and heart risks.

Last year, the Food and Drug Administration issued a safety alert on Avandia, made by British-based GlaxoSmithKline PLC, after another pooled analysis of studies found a risk of heart attacks. And in July of this year, FDA advisers said the agency should require drugmakers to show new diabetes drugs don't increase heart risks.

GlaxoSmithKline spokeswoman Mary Anne Rhyne said FDA-approved labeling for Avandia says available data on the risk of heart attack are inconclusive. The medication, approved in 1999, has been used by well more than 7 million patients, she said.

the details of the case: In the spring of 2000, Diana Levine of Vermont received treatment for migraines which consisted of the painkiller Demerol and Phenergan, an antihistamine manufactured by Wyeth Pharmaceuticals. Phenergan is typically injected directly into the muscle or dripped into the vein through steady doses (a procedure called an "IV drip"). When administering the drug, clinicians must be careful not to expose it to blood in the arteries; doing so causes "swift and irreversible gangrene," to use an evocative phrase from a September New York Timesarticle on Levine's case. Unfortunately, the physician assistant who attended to Levine administered Phenergan neither through muscular injection nor IV drip, but through a process called "IV push" -- a direct intravenous shot in the arm. The assistant missed and hit an artery. Over the next few weeks, Levine, who was an avid guitarist, saw her right hand and forearm turn purple and then black -- until both were finally amputated.

The court battle is over whether or not Wyeth Pharmaceuticals sufficiently warned against the dangers of IV push on its packaging for Phenergan -- packaging that had been approved by the FDA. The drug's labeling did warn that it was preferable to give Phenergan through IV drip, and warned that "inadvertent intra-arterial injection" -- accidentally injecting the drug into an artery -- could cause "gangrene requiring amputation." But nowhere on the Phenergan label was there an express warning that the method of IV push is extremely risky for this very reason.

In 2006, the Vermont Supreme Court upheld a jury decision in state court to grant Levine $6.7 million from Wyeth on grounds that the company should have more expressly prohibited IV pushing on the drug's labeling. Wyeth appealed, arguing that, because the packaging was FDA approved, patients had no right to question it through state laws. In effect, Wyeth claims that federal approval preempts state-based challenges to regulatory standards.

...

This case will make law. If the Court rules in favor of Wyeth, patients effectively lose their right to sue a drug company, even if its product harms them in an unexpected way. An FDA stamp of approval would essentially function as a shield from law suits.

Look at the flowers

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Someone needs to put a boot up the FDA's ass. They are getting paid off to approve shit not ready for the public. I see commercials every day about suing a drug manufacture because it caused ill effects or death. FDR is turning in his grave.

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Its partially the consumers fault too, No one wants to hear "Just go home, drink fluids, and get some rest". They demand meds, even if they don't really need them, then again who could blame them? You cant afford to miss a days work anymore.

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"Laws are like cobwebs, which may catch small flies, but let wasps and hornets break through." - Jonathan Swift

After reading "The Neurontin Legacy -- Marketing through Misinformation and Manipulation" in the January 8, 2009 issue of the New England Journal of Medicine, one may conclude that (1) America's prisons would be put to better use incarcerating drug company executives instead of pot smokers, and (2) society may need a return of public scorn via the pillory for those doctors who are essentially drug-company shills.

Drug-company corruption of American medicine is of course not news. What is news is that such corruption has become so egregious, so transparent, and so embarrassing that the New England Journal of Medicine, perhaps the most influential American medical journal, is now stating that "drastic action is essential to preserve the integrity of medical science and practice and to justify public trust."

Neurontin was approved by the Food and Drug Administration (FDA) in 1993 in doses of up to 1800 mg per day as adjunctive therapy for partial complex seizures. How did U.S. annual sales of Neurontin increase from $98 million in 1995 to nearly $3 billion in 2004? The answer is "off-label" marketing, in which Neurontin manufacturer Parke-Davis (a division of Warner-Lambert purchased by Pfizer in 2000) marketed Neurontin to doctors for uses not approved by the FDA (because doctors can legally prescribe drugs for uses not approved by the FDA).

While aggressive off-label marketing to doctors is standard among drug companies, it is routinely kept quiet. But thanks to a Parke-Davis whistle blower, we have first-hand evidence of off-label marketing -- and how the Neurontin financial bonanza was created.

In 1996, David Franklin, a young biologist, took a sales representative position for Parke-Davis. But shortly after beginning the job, Franklin grew concerned that he was participating in the illegal marketing of Neurontin. Franklin reports that a Parke-Davis executive informed him and his fellow sales reps:

"I want you out there every day selling Neurontin. . . .We all know Neurontin's not growing for adjunctive therapy, besides that's not where the money is. Pain management, now that's money. Monotherapy [for epilepsy], that's money. . . . We can't wait for [physicians] to ask, we need [to] get out there and tell them up front. Dinner programs, CME [continuing medical education] programs, consultantships all work great but don't forget the one-on-one. That's where we need to be, holding their hand and whispering in their ear, Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything. I don't want to see a single patient coming off Neurontin before they've been up to at least 4800 mg/day. I don't want to hear that safety crap either, have you tried Neurontin, every one of you should take one just to see there is nothing, it's a great drug."

Franklin left Parke-Davis and filed suit (ultimately, United States of America ex rel. David Franklin vs. Pfizer, Inc., and Parke-Davis Division of Warner-Lambert Company) alleging that off-label marketing of Neurontin constituted false claims designed to elicit payments from the federal government. In 2004, Warner-Lambert resolved criminal charges and civil liabilities by agreeing to plead guilty and pay $430 million -- less than 15 percent of the $3 billion the drug company had grossed on Neurontin in 2004.

The current New England Journal of Medicine article concluded that the marketing of Neurontin involved "the systematic use of deception and misinformation to create a biased evidence base and manipulate physicians' beliefs and prescribing behaviors." This is one of many examples:

"In a recently unsealed 318-page analysis of research sponsored by Parke-Davis, epidemiologist Kay Dickersin concluded that available documents demonstrate 'a remarkable assemblage of evidence of reporting biases that amount to outright deception of the biomedical community, and suppression of scientific truth concerning the effectiveness of Neurontin for migraine, bipolar disorders, and pain.' For example, publication was delayed for a report on a multi-center, placebo-controlled study that found no effect of Neurontin on the primary outcome measure for neuropathic pain because 'we [Parke-Davis employees] should take care not to publish anything that damages neurontin's marketing success.'"

Exactly what does it take for drug executives to do jail time?

And let's not kid ourselves about the innocence of doctors. The tactics used by Parke-Davis and other drug companies to manipulate doctors make it clear that too many doctors have been willing participants in the corruption of their profession.

The New England Journal of Medicine discusses some of the practices used by Park-Davis (and commonly used by other drug companies) recruit local physicians who are then trained and paid to serve as speakers in "peer-to-peer selling" programs; financially cultivate renowned professionals, so-called "thought leaders;" financially influence academics with educational grants, research grants, and speaking opportunities worth hundreds of thousands of dollars; create drug "advisory boards" to launder pay offs to "friendly" physicians; provide doctors employed by medical-education companies with "unrestricted educational grants" to produce programs that promote off-label (unapproved) uses of drug; fund doctors' "research" that in fact is designed and commissioned to promote a specific drug; and credit doctors as authors for ghost-written research articles that downplay drug ineffectiveness or lack of safety.

The New England Journal of Medicine is now warning physicians that medicine's corruption by drug companies has threatened public confidence in their profession. If those physicians who are not drug-company shills want to save their profession, they might want to start taking aggressive actions against their colleagues who are on the take. Perhaps it will help motivate clean physicians to be reminded that history shows that any institution -- no matter how large and powerful -- can arrogantly cross those lines leading to its demise.